FDA Approves CardioFocus' HeartLight Excalibur Balloon to Treat Paroxysmal Atrial Fibrillation
May 7, 2018—CardioFocus, Inc. announced that the US Food and Drug Administration (FDA) has approved the HeartLight Excalibur balloon, the company's next-generation technology designed for the treatment of paroxysmal atrial fibrillation (AF). The company expects to begin a full commercial launch of the Excalibur balloon in the United States in the third quarter of 2018.
According to CardioFocus, the Excalibur combines the balloon design of the company's FDA-approved HeartLight endoscopic ablation system with features that optimize the speed and magnitude of target tissue contact during pulmonary vein isolation procedures.
The Excalibur's ultracompliant design enables adaptive vein conformance. The device incorporates the company's Dynamic Response technology, which allows the user to make real-time adjustments to balloon size for optimal tissue contact. These combined features maximize the engagement of the balloon with the pulmonary veins, while decreasing the time required to complete ablation procedures, stated the company.
The company received CE Mark approval for the device in September 2017 and has launched it in Europe.
In the CardioFocus press release, Vivek Y. Reddy, MD, commented, "We have seen encouraging results with the Excalibur balloon. It obtains an impressive antral position and establishes even more tissue contact, which enables contiguous lesion sets. This is a clear advance in the field of balloon-based AF ablation, delivering on the promise of an ultracompliant balloon." Dr. Reddy is Director of Cardiac Electrophysiology and Helmsley Trust Professor of Medicine at The Icahn School of Medicine at Mount Sinai in New York, New York.